“How industry and regulators will use data to drive continuous improvement of products and better patient outcomes.” The recent pandemic has demonstrated the adaptability of humans during a global crisis. The use of novel technologies to manufacture vaccines, the regulatory approaches to see data review as an iterative process during the review of an application, as well as remote quality oversight of manufacturing sites have demonstrated the adaptability of the pharmaceutical / medical device industry. As we move to the post-pandemic phase, we should not lose these approaches instead they should be fostered as the routine within our organizations. How we use data over the lifecycle of products will become a competitive advantage to any organization that fully embraces “Big Data”.
While there have been many conferences on “Big Data”, the distinguisher for this event is the use of big data from a regulator and industry perspective in the context of quality and regulatory compliance. How do we use data contained within our quality systems, manufacturing sites, labs, etc. to drive continued product and process knowledge? We will listen to Regulators from the FDA, EMA, etc. as to how they use data provided by clinical trial sponsors, marketing authorization holders, manufacturers, parallel importers/distributors, post-market complaint and pharmacovigilance data to develop quality oversight. Leading industry speakers will discuss initiatives implemented in case of study format the “how-to” use this data to drive product and process improvements.
Looking forwrad to seeing you in Amsterdam!
Vinny Browning III, Amgen
Patrick Costello, AbbVie
Scientific Program Planning Committee
- Vinny Browning III, Amgen (Chair)
- Patrick Costello, AbbVie (Chair)
- Karin Baer, NeuroDerm Ltd.
- Daniel Davis, GSK
- Travis Frick, Adverum
- Jette Johansen, Novo Nordisk
- Peter Reichert, Zelect Quality IVS
- Eva Urban, CSL Behring
- Anette Yan Marcussen, Novo Nordisk
- Glenn Wright, PDA
- Falk Klar, PDA
- Sabine Hartmann, Manager Programs & Events, PDA